Reports And Records

I. Reports And Records 

 

1. IRB Reports To The NGHS Board Of Directors

a.   Annual Report (for activity from October, 1 to September, 30)
The IRB will issue an annual report that will summarize the activity. The minimum data reported will include:

Review activity:

• Initial Reviews by Full Board
  • Approved As Submitted
  • Approved Contingent
  • Returned With Questions
  • Disapproved
• Expedited Reviews
  • Approved As Submitted
  • Approved Contingent
  • Referred For Full Board Review
• Facilitated Reviews
  • Approved As Submitted
  • Approved Contingent
  • Referred For Full Board Review
• Contingencies Removed
• Continuing Review
  • Approved As Submitted
  • Approved Contingent
  • Returned For Clarification
  • Disapproved

b.   Occasional Reports
The IRB will report any problems with the current policies and procedures, forms, relationships, etc.

2. Other Reports 

a.   Minutes
The minutes will be in sufficient detail to summarize the major points of discussion and resultant actions. Every detail is not necessary if documentation is available in documentation linked to the minutes such as letters or file summaries.

21 CFR 56.115(b)

Minutes will record:

 Members present and absent

 Number of votes for and against any action and members abstaining

 The duration of the meeting

The minutes will be circulated to:

 The Director of Performance Improvement

 The Medical Executive Committee Chair

 The Pharmacy and Therapeutics Committee

b.    Drug Report
The IRB will generate a list of investigational drugs and devices receiving IRB approval for the information of the Pharmacy and the Pharmacy & Therapeutics Committee:

 Each investigational drug approved

 Title of study

 The Principal Investigator

 

3. Records of NGHS IRB

IRB records will be in the possession of and handled by NGHS IRB Coordinator, an employee of Northeast Georgia Health System.

Records will include:

1. Study files including the description of the study and of the test article, correspondence, the approved consent form and proposed advertising,
2. Minutes of all meeting(s),
3. Lists of the board members, their degrees and areas of expertise and their statements about conflict of interest.
4. Organizational files including guidelines, policies and procedures, bylaws, etc.

21 CFR 56.115(b)

 

All records will be considered confidential and will not be released except with the express permission of the subject or under court order. Inspectors from the FDA will be allowed to review and copy files.
 

4. Record Retention

All IRB records, hard copies and/or electronic copies, will be accessible to staff of the IRB Office.

Records of closed studies will be retained in hard copy for 3 years after the study has been closed to enrollment and there are no participants remaining in follow-up. After 3 years the records will be converted to electronic files for retention.

 

21 CFR 56.115(b)